Replaceable tip suturing devices, system, and methods for use with differing needles

ABSTRACT

Medical suturing devices, systems, and methods will be useful for endoscopic or open surgeries, including ear, nose, and throat procedures. Articulation motions may be transferred from a handle to needle grasping jaws using an axial movement of a shaft. Portions of the devices may be disposable, replaceable, and/or reusable, with different needle-grasping jaws and/or different elongate extension bodies having different configurations optionally being selectably coupleably to an articulatable handle and housing so as to allow the user to configure the device for a particular procedure.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.12/049,545, filed on Mar. 17, 2008, which claims the benefit of priorityfrom U.S. Provisional Patent Application No. 60/895,058, filed on Mar.15, 2007 and entitled “SUTURING DEVICE, SYSTEM, AND METHOD”, the fulldisclosure of which is incorporated herein by reference.

The subject matter of this application is related to that of U.S. patentapplication Ser. No. 12/049,552, filed Mar. 17, 2008 and entitled“LIMITED ACCESS SUTURING DEVICES, SYSTEM, AND METHODS”; and to that ofU.S. patent application Ser. No. 11/532,032, filed Sep. 14, 2006 andentitled “SUTURING DEVICE, SYSTEM, AND METHOD”; which is acontinuation-in-part of U.S. patent application Ser. No. 11/227,981filed Sep. 14, 2005, the full disclosures of which are incorporatedherein by reference.

BACKGROUND OF THE INVENTION

The present invention generally relates to medical devices, systems, andmethods. In specific embodiments, the invention provides devices,systems, and methods for suturing tissues in open surgery, minimallyinvasive surgical procedures, and the like.

Although many aspects of surgery have changed radically over the lastseveral decades, some surgical techniques have remained remarkablyconstant. For example, as was true fifty years ago, suturing remains acommon technique for approximation of tissues, ligation of tissues,affixing tissues together, and the like.

Suture has been used in open surgical procedures for generations totherapeutically treat diseased tissue and to close surgical access sitesand other wounds. More recently, the use of minimally invasive surgicaltechniques has expanded, with surgical therapies often being performedat internal surgical sites. Although a wide variety of visualizationtechniques (including laparoscopes and other endoscopic viewing devices,fluoroscopy and other remote imaging modalities, and the like) have beendeveloped to allow surgeons to view these internal surgical sites, andalthough a large variety of new tissue treatment techniques have beendeveloped (including ultrasound techniques, electrosurgical techniques,cryosurgical techniques, and the like) and are now widely available,many modern surgical interventions continue to rely on suturing.

A wide variety of alternatives to suturing of tissues have beendeveloped, and have gained varying degrees of acceptance in certainsurgical procedures. Staples and tissue adhesives are used quitefrequently in many open and minimally invasive surgical settings, and avariety of tissue welding techniques have also been proposed.Nonetheless, suturing remains ubiquitous in surgery, as suturingprovides a number of advantages over many of the alternatives.

Suture's advantages include the large knowledge and skill base thatsurgeons have developed over the years. Additionally, a variety ofoff-the-shelf, pre-packaged surgical needles with suture are availablefrom a large number of suppliers at very reasonable cost. Surgeons areable to precisely control the location of suture stitches by graspingthe suture needle and first pushing it and then pulling it through thetarget tissue. In open surgery the surgeon may manually grasp the sutureneedle directly with his or her hand, although both open and minimallyinvasive procedures are often performed by grasping the needle with aneedle grasping tool and manipulating the tool to place the suturestitches. The results obtained using suture are highly predictable,although dependent on the skill of the surgeon. In light of itsadvantages, the use of suture does not appear likely to disappear anytime soon, with even modern robotic surgical techniques often making useof suture.

Although suture remains popular in surgery at least in part due to itssignificant advantages, suturing is not without disadvantages. Inparticular, placing a large number of suture stitches can be tiring andquite time-consuming. Manipulation of a suture needle can be difficulteven in open surgery due to the limited space that is often availablearound the target tissues. The challenges of manipulating suture needlesmay be even greater in minimally invasive surgical procedures, where theneedles are often manipulated using long-handled tools extending througha small aperture, typically while viewing the procedure on a displaywhich is offset from the surgical site. Tying knots with a desiredamount of tension and the like may call for intricate and precisemanipulation of the suture, further complicating and delaying open andminimally-invasive surgeries. In fact, the time spent closing/suturingthe access site may be significantly greater than the time spenttreating the underlying target tissues for many procedures.

There have been a variety of proposals for modifications to standardsurgical suturing structures and methods to try to address the abovedisadvantages. At least some of these proposals may seek to rely onspecialized and/or proprietary suturing needle systems, which couldincrease costs and preclude their wide acceptance, especially in thirdworld countries. Unfortunately, many proposals for modifying existingsuturing techniques may also decrease the surgeon's control over theplacement of the suture, such as by relying on an automated or indirectmechanical movement of a device to drive a suture needle into and/orthrough tissues. While these new proposals have in the past or may inthe future gain varying degrees of acceptance in one or more surgicalprocedures, standard suturing techniques continue to predominatethroughout surgery in general.

In light of the above, it would be desirable to provide improvedsuturing devices, systems, and methods. It would be generally desirableto maintain some, most, or all of the advantages of standard suturingtechniques, preferably while decreasing the time required for suturing,the strain on the surgeon, the training involved in achieving competenceor time-efficiency in suturing techniques, or the like. It would beparticularly advantageous if these improvements could be providedwithout requiring extensive capital investments for new equipment,without significant increases in complexity of the suturing process, orwithout having to resort to specialized or proprietary suturing needlesand the like. Alternative needle grasper structures which increased theease and accuracy of stitching, and/or which are readily adapted for avariety of different procedures and patient physiologies would also bedesirable.

BRIEF SUMMARY OF THE INVENTION

The present invention generally provides improved medical suturingdevices, systems, and methods. Embodiments of the invention provideimproved suturing systems, devices and methods that maintain some or allof the advantages of standard open and/or minimally invasive suturingtechniques while providing enhanced speed and ease of use. While someembodiments will find uses in a wide range of open surgical procedures,many advantageous embodiments will be particularly useful for endoscopicsurgeries. Articulation motions may be transferred from a handle toneedle grasping jaws using an axial movement of a shaft that has axialstiffness (such as being stiff in compression or the like) and lateralflexibility, allowing an extension body (within which the shaft moves)between the handle and jaws to be pre-bent or custom bent by the userfor a particular surgery. Portions of the devices may be disposable,replaceable, and/or reusable, with different needle-grasping jaws and/ordifferent elongate extension bodies having different configurationsoften being selectably coupled to an articulatable handle and housing soas to allow the user to configure the device for a particular procedure.Exemplary embodiments include a re-usable drive body containing at leasta portion of a drive linkage and a plurality of alternatively selectableclamp units, with the clamp units being configured to accommodate thegeometry of differing suture needles.

In a first aspect, the invention provides a suturing system for use witha first suturing needle or a second suturing needle. The systemcomprises a body having a proximal end and a distal end. At least oneclamp is mountable near the distal end of the body, and a linkageeffects a movement of the at least one clamp between a graspingconfiguration and a released configuration. The linkage has a firstconfiguration and a second configuration, the linkage in the firstconfiguration applying a first clamping of the clamp(s) suitable forsuturing with the first suturing needle when the linkage effectsmovement from the released configuration to the grasping configuration.The linkage in the second configuration applies a second clamping of theclamp(s), suitable for suturing with the second needle when the linkageeffects movement from the released configuration to the graspingconfiguration.

In many embodiments, the first needle will define a first arc, thesecond needle will define a second arc different than the first arc, andthe suturing system will also include a first clamp unit and a secondclamp unit. Each clamp unit can be removably mountable to the body andinclude an associated plurality of clamps. The clamps are configured tosequentially grasp an associated needle when the clamp unit is mountedto the body and the linkage is cycled. The clamps of first clamp unitdefine a first clamping offset angle corresponding to the first arc,while the clamps of second clamp unit define a second clamping offsetangle corresponding to the second arc. Hence, replacement of the firstclamp unit with the second clamp unit reconfigures the linkage from thefirst configuration to the second configuration.

In another aspect, the invention provides a suturing system for use witha first suturing needle having a first needle geometry and a secondsuturing needle having a second needle geometry different than the firstneedle geometry. The system comprises a drive unit having a body with aproximal end and a distal end. A first clamp unit is mountable near thedistal end of the body and includes a plurality of clamps. A secondclamp unit is mountable near the distal end of the body and alsoincludes a plurality of clamps. A linkage operationally couples thedrive unit to an associated clamp unit mounted thereon. The linkageeffects sequentially alternating grasping and releasing by the clamps ofthe first clamp unit when the first clamp unit is mounted to the driveunit and the linkage is cycled. The grasping of the first clamp unitcorresponding to the geometry of the first needle. The linkage alsoeffects sequentially alternating grasping and releasing by the clamps ofthe second drive unit when the second clamp unit is mounted to the driveunit and the linkage is cycled. The grasping of the second clamp unitcorresponds to the geometry of the second needle.

The clamps of the first drive unit will often be laterally separated soas to grasp the first needle sufficiently near opposed ends of theneedle so as to allow the needle to be advanced into and through atissue region while held with one clamp, and so as to allow the needleto be grasped and pulled free of the tissue by the other clamp. Cyclingof the linkage effects needle movement relative to the body which isinsufficient to advance the first needle through tissue so that suturingis instead effected by moving the body relative to the tissue.

Each clamp often articulates with cycling of the linkage so as to graspthe needle laterally relative to a local axis of the needle. The clampsof the first clamp unit may be angularly offset by a first angle so asto accommodate a first arc angle of the first needle geometry betweenthe clamps, while the clamps of the second clamp unit can be angularlyoffset by a second angle so as to accommodate a second (and different)are angle of the second needle geometry between the clamps. The clampinggeometry may also vary between the clamp units to reflect differences inradii of curvature of the needles, length of the needles (andappropriate tissue suture or needle insertion and exit separations), andthe like. In some embodiments, the clamps may be supported by tubularextensions that accommodate shaft motion to articulate the clamps, withthe extensions residing on the drive unit, clamp unit, or both. Theextensions of at least one clamp unit may angle outwardly and distallyso as to accommodate a larger needle than another clamp unit havingextensions that are parallel to each other. Alternative extensions mayangle inwardly and distally so as to accommodate smaller needle sizes.The needle size may correspond to the length of the extensions, evenwhere the angles between extensions of different clamp units are thesame. In some embodiments, the extensions may articulate from a parallelorientation to an angled orientation with cycling of the linkage, suchas through the use of a straight or curved cam-and-follower arrangementor the like supporting the extension. Optionally, each suturing needlemay comprise an off-the-shelf suturing needle having a standard sizeidentifier associated therewith. Each clamp unit may have indicia of anassociated needle size visible thereon so as to facilitate selection ofan appropriate clamp unit for use.

In many embodiments, the clamp units may include one or more polymer(such as a plastic, high density polyethylene, or the like), with atleast the needle engaging surfaces of the clamp units including metal(such as a medical grade stainless steel, stainless steel alloy,titanium grades 1-4, or the like). The drive unit may include metal(and/or any of the materials listed above for the clamp unit) and willoften be configured to withstand repeated sterilization.

In another aspect, the invention provides a suturing system for use witha plurality of differing suturing needles. The system comprises a driveunit having a body with a proximal end and a distal end. A plurality ofalternative clamp units may be releasably mountable to the distal end ofthe drive body. Each clamp unit can have a plurality of clamps forengaging an associated plurality of locations of an associated needle.The clamps of the clamp units can define different geometries so as toaccommodate the differing needles and their use for suturing differingtissues.

In another aspect, the invention provides an apparatus for use with asuture needle. The needle may be selected from among a plurality ofdiffering suturing needles, with each needle having an axis. Theapparatus may also be for use with a drive unit having a body with aproximal end and a distal end, an interface near the distal end, and adrive unit linkage portion. The apparatus may comprise a clamp unitreleasably mountable to the interface of the drive body. The clamp unitmay have a plurality of clamps and a clamp unit linkage portion actuatedby the drive unit linkage portion. The clamp unit can be mounted to thedrive unit and, in use, the linkage may alternatingly actuate theclamps. The clamps may define a geometry corresponding to the selectedneedle so as to grasp axially separated locations of the needle.

In yet another aspect, the invention provides a suturing apparatus foruse with a plurality of differing suturing needles and an associatedplurality of alternative clamp units. The clamp units each having aplurality of clamps for engaging an associated plurality of locations ofthe associated needle, the clamp units defining different geometrytherebetween so as to accommodate the differing needles. The apparatuscomprises a drive unit having a body with a proximal end and a distalend. An interface may be disposed near the distal end of the body, theinterface selectably receiving any of the plurality of alternative clampunits. A drive linkage portion may be configured to drivingly couple tothe clamps of the selected clamp unit mounted to the interface so as toalternately articulate the clamps suitably for grasping the associatedneedle.

In other embodiments, related suturing devices may have bodies(optionally being incorporated into either the drive body or the clampunit or both) that including an elongate extension extending along anaxis toward the distal end. The extension may define a bend in the axis,with a first clamp being disposed near the distal end of the body. Thelinkage may comprise a shaft or tension member movable along the axiswithin the extension so as to effect the movement of the clamp. Theshaft may be laterally flexible so as to transmit axial movement andaccommodate the bend. The extension may comprises a plasticallydeformable tubular body sufficiently stiff to allow support the needlerelative to the proximal end during suturing, and sufficientlydeformable to allow manual imposition of the bend, preferably withoutcollapsing or kinking of a tubular opening in the extension thatreceives the shaft. Alternative embodiments may be pre-bent.

The clamps may comprises first and second jaw elements, each havingneedle grasping surfaces, wherein each jaw element has a slide surfacefor slidably engaging a wedge surface of the linkage. Axial movement ofa shaft within a tubular body of the drive unit and/or clamp unit canthereby effect sliding movement of the wedge along the slide surfaces ofthe jaws so as articulate the clamp. In some embodiments, axial movementof the wedge in a first axial direction forces the clamp toward a closedconfiguration, while axial movement of the wedge in a second axialdirection allows a spring to urge the clamp open with a spring-imposedjaw opening force. At least a portion of the shaft will often be movableaxially to articulate the clamp, and the shaft and tubular bodies willbe releasably coupleable to corresponding structures of the drive unitvia a quickly replaceable clamp unit interface. A plurality ofalternative releasably attachable clamp units may also be provided, thevarious clamp units, when mounted to the proximal portion, definingdifferent bend angles, extension lengths, clamping forces, needle sizes,and/or clamp types. The clamp unit may comprises one or more polymer,and the needle grasping surfaces of the clamp unit may comprise a metalso that the clamp unit is disposable. In other embodiments, the clampunit comprises metal and is configured to withstand repeatedsterilization.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an exemplary embodiment of a suturingdevice with one of the clamps of the suturing device grasping a suturingneedle.

FIG. 2 is a perspective view of a proximal portion of the suturingdevice of FIG. 1, with a cover removed from a proximal housing of thesuturing device to show a portion of a linkage coupling a handle of thesuturing device to the clamps of the suturing device.

FIG. 3 is an exploded perspective view of components of the linkageshown in FIG. 2.

FIG. 4 is an exploded view of a distal portion of the suturing device ofFIG. 1, showing components of a clamp along with a reciprocatable shaftand elements of the linkage that effect movement of the reciprocatableshaft and actuation of the clamp.

FIGS. 5-9 are perspective views showing use of the device of FIG. 1 forsuturing tissues.

FIG. 10 is a perspective view of an alternative suturing device havingfirst and second clamps which both reciprocate and rotate away from asuturing needle after releasing of the needle from the clamp.

FIGS. 11A and 11B illustrate an exemplary suturing device in which theclamps are releasably coupled to the body of the device, allowing theclamps to be disposable to avoid cross contamination between differingpatients without having to sterilize the clamp structures.

FIGS. 12A and 12B are a side view and top cross-sectional view,respectively, of another embodiment of a suturing device having a drivelinkage with an alternatable drive element for moving first one clampand then the other, and also having an alternatable latch for inhibitingmovement of the clamp that is not being driven.

FIG. 13 is an exploded view schematically showing some of the componentsof the drive linkage of the suturing device of FIGS. 12A and 12B.

FIGS. 13A-13M are cross-sectional views schematically illustratingactuation of the linkage of the suturing device of FIGS. 12A and 12B.

FIGS. 14A-14C are perspective views of a distal portion of analternative suturing mechanism in which axially offset clampsalternately grasp proximal and distal portions of a ski-jump suturingneedle.

FIG. 15 is a perspective view of an alternative suturing device having asingle needle-grasping clamp.

FIG. 16 is a side view schematically illustrating a suturing devicesimilar to that of FIG. 12A in which an extension of the body betweenthe clamps and proximal housing has been manually bent for a particularpatient, in which the clamps are actuatable through the bent extension,and which is being grasped by a hand of a surgeon.

FIGS. 17A-D schematically illustrate an alternative suture device havinga plastically bendable extension and a laterally flexible shaft so as tofacilitate custom bending or configuring of the suture device by theuser for a particular surgery.

FIGS. 18A-18C illustrate a perspective view, a side view, and anexploded view, respectively, of an alternative embodiment of a suturingdevice similar to that of FIGS. 11A and 11B, in which the clamps areincluded in a rapidly detachable clamp unit, and in which the clamp unitis latched to the drive unit by sliding a cover of the drive unitdistally.

FIG. 19 schematically illustrates a suture system having a plurality ofdiffering needle sizes or types, an associated plurality of differingclamp units, and a drive unit that removably receives any of the clampunits.

FIGS. 20A-20C schematically illustrate differing suture needle sizeshaving differing geometry, along with simplified associated differingclamp geometry of suturing devices for manipulating those needles.

FIGS. 21A-21C are perspective views showing an assembled suture systemhaving extensions which angle outwardly distally of the drive unit so asto accommodate a large needle, the associated angled clamp unit, and theassociated drive unit, respectively.

FIGS. 22A and 22B schematically illustrate differing angled clamp unitextensions having a common angle and differing lengths so as toaccommodate differing needle sizes.

FIGS. 23A-23C schematically illustrate how appropriate overshoot of theclamps and stressing of the needle can help maintain positioning of theneedle relative to the clamps when the needle geometry and clampgeometry correspond.

FIGS. 24A-24C schematically illustrate actuation of a clamp unit havingangled extensions.

FIGS. 25A-25C illustrate differing clamp units and their indicia ofassociated needle sizes or types.

FIG. 26 illustrates a clamp unit having an elongate extension for use inminimally invasive surgery.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is generally directed to improved medical suturingdevices, systems, and methods. Exemplary embodiments of the inventionprovide improved suturing devices and methods for suturing tissues thatcan significantly increase the speed and ease of suturing, particularlywhen suturing of long incisions or where large numbers of stitches areto be deployed.

The invention should find a wide variety of applications for stitchinganatomical tissues in both humans and animals. Along with endoscopicoperations (for example, in laparoscopy) these structures and methodsmay find use in other areas of surgery where tissues are to be stitched,providing particular advantages for stitching of large incisions byincreasing the ease and speed with which each individual stitch may beplaced, as well as facilitating and expediting the formation of knots inthe suture. The suturing devices and associated methods described hereinmay, for example, be used to suture a wide variety of strata ofanatomical tissues, including (but not limited to) subcutaneous layers,fascia, the outer skin, various organs (including the uterus), and thelike. While exemplary embodiments are set forth below, these suturingdevices and methods may be applicable to a wide variety of suturingoperations, including open surgery, large and small cavity procedures,endoscopic procedures, microsurgeries (including for suturing of veins,arteries, tissues of the eye and the like), and many specializedsurgeries. Embodiments of these devices and methods may be particularlyuseful for surgeries involving long incisions, including plasticsurgeries. A wide variety of blood vessels, including both veins andarteries, may also be stitched using the techniques described herein,for formation of anastamoses and the like. Along with increasing thespeed and/or ease of forming surgical suture stitches, embodiments ofthe invention will often maintain the control a doctor has over theplacement of the sutures by maintaining a fixed relationship between themovements of the doctor's hand and the insertion and withdrawal of thesuturing needle. Hence, among the procedures which may benefit from theinvention are subcuticular peritoneum, fascia closure, and skin closure,and the like. Exemplary uses may include therapies in the fields ofobstetrics and gynecological surgeries (including cesarean sections,hysterectomies, and the like), cosmetic surgeries, ophthalmic surgeries,and the like.

While embodiments of the invention may include (or be used within) apowered or automated system, optionally making use of electromechanicalpower, hydraulic power, or the like (for example, with some embodimentsbeing included within a robotic system), other embodiments may beconfigured for manual manipulation by one or more hands of a surgeon,often without having to resort to complex subsystems or external power.

Many embodiments of the devices described herein will be sterilizable soas to allow repeated use. Sterilization may be effected using autoclavetechniques, chemical sterilization, irradiation, or the like, with mostor all of the structures of the suturing device being formed ofmaterials suitable for repeated sterilization (such as stainless steel,other metals and alloys, and the like). In general, the suturing devicemay also comprise one or more plastics and/or metals common to surgicaldevices. Although specialized or proprietary suturing needles may beemployed in some embodiments (for example, needles having flat grippingsurfaces so as to maintain an alignment between the needle and anassociated clamp), many embodiments of the suturing device will besuitable for use with standard off-the-shelf suture needles such asthose packaged with any of a wide variety of permanent or resorbablesuture materials in a hermetically sealed package. In fact, theinvention may find some of its most immediate applications forfacilitating surgical procedures performed manually in Third Worldcountries, allowing physicians to treat a larger number of patients withgreater ease than can be done using standard suturing techniques, butwithout the cost or complexity of recently-proposed automated suturingsystems.

Referring now to FIG. 1, an exemplary suturing system 100 generallyincludes a suturing device 102 and a needle 1. Needle 1 generally has aproximal end 104 and a distal end 106, with at least the distal endbeing sharpened to facilitate insertion of the needle distally into andthrough tissues. Surgical needles are often formed with a curving shapebetween the proximal and distal ends, and are often packaged with asuture extending from proximal end 104, with the needle sometimes beingreferred to as an acus.

Suturing device 102 generally has a body 112 having a proximal end 108and a distal end 110. A pair of clamps 3 are disposed near the distalend 110, while first and second handles 6, 8 are disposed near proximalend 108. Body 112 may include a proximal housing 7 and a distalextension 4. The distal extension may have a pair of channels, with eachchannel reciprocatably receiving a shaft 2 supporting an associatedclamp 3.

In this embodiment, clamps 3 are mirror-symmetric, although they mayalternatively have differing shapes. Clamps 3 are generally offset so asto grip axially offset portions of needle 1, with one of the clampsgripping a more proximal portion of the needle and the other clampgripping a more distal portion of the needle. When handles 6, 8 are in aclose-handed configuration as illustrated in FIG. 1, only one of clamps3 will typically grip needle 1, the other clamp being retractedproximally away from the needle. Handles 6, 8 have openings forreceiving fingers of the surgeon's hand, and the surgeon will typicallyactuate the handles by opening them from the closed-handed configurationshown to an open-handed configuration 114. Starting with handles 6, 8 inthe closed (as shown in FIG. 1), when the handle is moved to open-handedconfiguration 114 and is then returned to the closed-handedconfiguration, the handle may be described as having completed anactuation cycle.

With each actuation cycle of handles 6, 8, the clamp 3 supporting needle1 is alternated so that a needle initially supported by grasping theneedle in first clamp along a proximal portion of the needle will, whenhandles 6, 8 are in open-handed configuration 114, instead be supportedby the second clamp along a more distal portion of the needle. Ashandles 6, 8 move back to the closed-handed configuration to completethe cycle, the clamps again alternate, so that closing of the handleresults in extension of the proximal clamp, gripping of needle 1 withthat proximal clamp, release of the needle from the distal clamp, andretraction of the distal clamp. The position of needle 1 relative tobody 112 may remain substantially fixed throughout the handle actuationcycle, although the shafts may move axially slightly as the needle goesfrom being held by one clamp, to both clamps, and then to the otherclamp, with this movement of the needle being less than a length of theneedle.

Referring now to FIGS. 1 and 2, handles 6, 8 are pivotally attached tohousing 7 of body 112. Housing 7 generally includes at least one lid 9(the top lid shown removed in FIG. 2), with the proximal housingpreferably including opposed first and second lids 9 on opposed majorsurfaces of the body. Lids 9 and the other structures of housing 7generally enclose a drive linkage 116 coupling handles 6, 8 to clamps 3.In the embodiment of FIGS. 1-9, drive linkage 116 generally includes adrive wheel 11 and two driven wheels 10 and 12. The driven wheels 10 and12 are mirror-symmetric and joined by tie rods 14 and 21 to clamps 3.

Referring now to FIGS. 1-3, driven wheel 10 has a thrust surface 24,while driven wheel 12 has a stop surface 23 and an incline 22. Thedriving wheel is supported so as to rotate about an axle 20, the drivingwheel also having a lug 13. The driving wheel 11 is coupled to handles6, 8 by ties 18 and 19, so that actuation of the handles relative to thebody 7 induces rotation of driving wheel 11 about the axle. The drivenwheels 10, 12 rotate coaxially with driven wheel 11.

Lug 13 generally comprises an alternatable configuration drivingelement. Lug 13 either drivingly couples driving wheel 11 with drivenwheel 10, or with driven wheel 12, depending on the configuration of lug13 at the time. More specifically, when lug 13 is disposed above a guide15 as shown in FIG. 2, the lug drivingly couples the driving wheel 11with the upper driven wheel 10. When lug 13 is disposed below guide 15,the lug drivingly engages driven wheel 12, and is disengaged from drivenwheel 10. A reset or release input button 16 interacts with guide 15 anda spring-loaded positioning arm 17 so as to allow both clamps 3 torelease needle 1.

As can be understood with reference to FIGS. 1-4, each clamp 3 isconnected by an associated shaft 2 to the remaining components of drivelinkage 116. Shafts 2 each include a lengthwise slot 118 (see FIG. 4),which allows the shaft to move within the channels of body extension 4.Guiding pins 32 ride in slots 118, and the guiding pins 32 are alsofixed in extensions 4 within openings 5.

Moving wedges 31 within shafts 2 also have lengthwise slots 118 forreceiving guiding pins 32. The wedge surfaces of moving wedges 32 engagecorresponding surfaces of working 10 jaws 25, with the working jawsforming the open and closable structure of clamps 3. More specifically,distal movement of moving wedge 31 against a corresponding surface ofworking jaws 25 closes clamps 3, the working jaws being attached to adistal clevis of shaft 2 by axle 27. A spring ring 30 biases workingjaws 25 to an open configuration, allowing them to move around andcapture needle 1 before the working jaws are forced shut by the movingwedges.

Working jaws 25 may have a variety of surfaces for holding needle 1, theclamps preferably holding the needle so that movement of the needlerelative to suturing device 100 is inhibited during stitching. Thesurfaces of working jaws 25 may be hardened by deposition of diamond ora diamond-like carbon, or inserts 26 of a material harder than that ofworking jaws 25 may be provided. Optionally, working jaws 25 may havehard-surfaced inserts comprising tungsten and/or cobalt, with theinserts optionally being fabricated using powder sintering or the like.

A return spring 28 extends between pin 28 in working jaws 25 and theguiding pin 32, with the return spring partially fixed within a lumen ofmoving wedge 31. A spring 34 in the proximal portion of moving wedge 31is held by a plug 37, with the distal end of spring 34 interacting withshaft 2 via thrust ring 33. Spring 34 can bring the moving wedge 31 intoa position suitable for releasing the working jaws. A compensationspring 36 pressed against plug 37 writes on a rod 35 of a pusher 42 soas to maintain a desired axial force. Pusher 42 has an insert 40, whichis connected with the pusher 42 by pin 39 and lug 38. The lug rotatesabout axle 41.

When handles 6 and 8 are moved apart to an open-handed configuration114, a retracted clamp 3 and its associated shaft 2 moves from within achannel of body extension 4. While retracted, the moving wedge 31 isbiased by spring 34 away from working jaws 25, so that spring ring 30 isfree to open the clamp to allow it to extend around needle 1. Extensionof compensating spring 34 may be at its greatest point while theassociated clamp 3 is retracted, and insert 40 extends from pusher 42with lug 38 in the insert.

As handles 6 and 8 are brought together, driving wheel 11 is turned byconnector ties 18, 19. Lug 38 interacts with thrust surface 24 of drivenwheel 10 and moves the driven wheel 10 in rotation. The motion of drivenwheel 10 is transferred by tie rod 14 so as to move insert 40 axiallyalong body extension 4. The insert, in turn, moves the pusher 42 alongbody extension 4, the relative position of the insert 40 and pusher 42being maintained by an inner surface of shaft 2 interacting with plug 30so as to inhibit rotation of the plug about axle 41. Pusher 42 pressesspring 34 and compensation spring 32, and via plug 37 and thrust ring33, moves shaft 2. The movement of shaft 2 overcomes spring 29 andextends the shaft from the channel of body extension 4.

During distal movement of pusher 42, spring 34 and compensating spring36 are sufficiently stiff so as to inhibit elongation, as their springcoefficients are significantly higher 15 than that of return spring 29.However, engagement between an end of slot 118 in shaft 2 and guidingpin 32 eventually inhibits further distal movement of the shaft.

Once shaft 2 has stopped its distal movement (due to engagement oflengthwise slot 118 with guiding pin 32), spring 34 begins to contract,its rigidity being lower than that of compensating spring 26. As aresult, moving wedge 31 begins to extend distally relative to workingjaws 25, the corresponding surfaces of the wedge and working jawssliding against each other so as to move the proximal ends of theworking jaws apart and bringing the distal needle gripping inserts 26 ofworking jaws 25 together so as to grasp needle 1. As spring 34contracts, contraction of compensation spring 36 also begins and theinsert 40 moves. When lug 38 extends into and/or engages window 2 a ofshaft 2, pusher 42 engages a surface of body extension 4 or proximalhousing 7, and axial movement of the pusher stops. Insert 40 continuesmoving, so that lug 38 rotates around axle 41. The lug interacts with anedge of shaft 2 and, overcoming compensation spring 36, starts to drawshaft 2 and its contents into body extension 4.

The clamping force on needle 1 by clamps 3 may be determined by thespring characteristics of compensating spring 36 so as to remain withina desired range. Advantageously, the clamping force imposed by suturingdevice 100 on needle 1 may correspond to forces applied by standardneedle holders. Thrust surface 23 of driven wheel 12 approaches a toothof spring-loaded fixing arm 17, and overcoming the spring, the thrustsurface passes under the tooth, releasing the tooth so that the toothand thrust surface are positioned for neutral engagement. After thethrust surface 23 of the driven wheel 12 passes beyond the tooth ofspring loaded fixing arm 17, engagement of the thrust surface and toothinhibit the return of the driving linkage 116 to its priorconfiguration, thereby inhibiting the release of needle 1 from theclosed working jaws 25 so that the needle is not dropped.

As handles 6, 8 continue to move toward the open-handed configuration ofthe handle actuation cycle, movement of driven wheel 12 is inhibited byspring-loaded fixing arm 17. Driving wheel 11 nonetheless turns, and isreset. More specifically, incline 22 of driven wheel 12 moves lug 13from a configuration above guide 15 to a configuration in which the lugis disposed under the guide. Hence, when handles 6, 8 continue to move,here towards a closed-handed configuration, the lug 13 will interactwith thrust surface 24 of the driven wheel 10. The description aboveregarding driven wheel 12 is thus repeated but with driven wheel 10instead. When moving under the spring-loaded fixing arm 17, the thrustsurface 23 of driven wheel 12 lifts the spring-loaded fixing arm 17 andreleases driven wheel 10.

By action of spring 34, moving wedge 31 is retracted proximally frombetween the proximal ends of working jaws 25, so that the proximal endsof the working jaws are brought together by spring-loaded ring 30.Distal ends of working jaws 25 thereby move apart and the needle isreleased.

Each repeated opening and closing actuating cycle of handles 6, 8alternates the needle between being held by one, and then the other ofclamps 3, and often back to the first clamp. In other embodiments, eachhandle actuation cycle effects transfer of the needle from one clamp tothe other, with the needle returning to be held solely by the firstclamp only with a second handle actuation cycle. Regardless, during eachcycle each retracted clamp is preferably extended around an associatedportion of needle 1 and is closed before the previously extended clampopens, so that the needle is held continuously by at least one of clamps3 throughout the handle actuation cycle.

If it is desired to release needle 1 from suturing device 112 at anytime during, before, or after a handle actuation cycle, release can beeffected by pressing on release input button 16. Pressing on button 16causes spring-loaded fixing arm 17 to lift away from driven wheels 10and 12, thereby resetting the clamps in their proximal openedconfiguration.

Referring now to FIGS. 5-9, the use of suturing device 102 for suturingan incision I in tissue T can be understood. Initially, handles 6, 8(see FIG. 1) are in a closed-handed configuration and the handles aregrasped by a hand of a surgeon. Needle 1 is supported by a first clamp 3a, with the first clamp grasping a proximal portion of the needleadjacent a suture S. The second clamp 3 b is retracted proximally awayfrom needle 1, so that a distal portion of the needle is free andexposed, as illustrated in FIG. 5.

As can be understood with reference to FIG. 6, the surgeon manuallymoves suturing device 102 by manipulating handles 6, 8 so as to insert adistal portion of suturing needle 1 through tissue T. Advantageously,body 112 and linkage 116 (see FIG. 2) of suturing device 102 inhibitsrelative movement of needle 1 relative to the body and handles 6, 8 ofthe suturing device while the handles are closed. This allows thesurgeon to precisely control movement of the needle 1 as it is insertedthrough the tissue, in a manner analogous to manual manipulation of theneedle using a standard needle grasper or forceps. As can be understoodwith reference to FIGS. 6 and 7, once the distal portion of needle 1extends sufficiently through the tissue, handles 6, 8 can be cycledthrough at least a portion of their actuation cycle. Through the linkage116, second clamp 3 b is extended distally from body 112 of suturingdevice 102, grasping the distal portion of needle 1. The first clamp 3 athen releases needle 1 and is withdrawn proximally from around theneedle, as illustrated in FIG. 8.

As can be understood with reference to FIGS. 8 and 9, once needle 1 isheld by second clamp 3 b, the surgeon can again manipulate the needle bymoving handles 6, 8. In some embodiments, the surgeon can grasp thehandles in an open-handed configuration while pulling the needle freefrom the tissue, while in other embodiments the needle will be pulledafter the handle has returned to the closed-handed configuration.Regardless, the surgeon uses the handles, body, and clamp 3 b to pullthe proximal portion of needle 1 through tissue T, thereby leavingsuture S inserted across incision I.

Prior to initiating a second stitch, the surgeon can cycle handles 6, 8by closing the handles with his/her hand, or by opening and closing thehandles through a full actuation cycle. This results in grasping ofneedle 1 by first clamp 3 a and release of the needle by second clamp 3b, exposing the distal portion of the needle and displacing the secondclamp from the needle so that the needle is ready to again insertthrough tissue T, as can be understood with reference to FIG. 5. Theprocess can then be repeated without ever having to completely releaseneedle 1, and by simply actuation of handles 6, 8 after insertion of thedistal portion of the needle through the tissue and again after eachpulling of the needle free. The process is repeated to form as manystitches as is desired. Analogous insertion of the distal portion of theneedle through loops of suture, actuation of the handle, and pulling theneedle free can be used to quickly and easily form knots.

As can be understood from the illustrations in FIGS. 5-9, and as may beindicated by the detailed description above of the articulation of thedrive linkage, shafts 2 extending distally from body 112 to clamps 3 a,3 b may move slightly during the handle actuation cycle, for example,with the shaft supporting the clamp initially holding needle 1retracting slightly into body 112 as the other shaft extends.Nonetheless, each clamp holds the needle at a fixed location while thesurgeon holds the handles 6, 8 in the closed configuration and insertsor withdraws the needle into or from the tissue.

Referring now to FIG. 10, a wide variety of alternative linkagemechanisms, clamp structures, housing, handles, and the like may beemployed, as more fully described in US Patent Publication No.2007/0060931. For example, as seen in FIG. 10, an alternative suturingdevice 130 may include clamps 43, 44 which both retract proximally androtate away from needle when not used to hold the needle.

Referring now to FIGS. 11A and 11B, an alternative suturing devicesystem 202 may include many functional components which are similar tothose described above, but can generally be separated into a reusabledrive unit 204 and a disposable clamp unit 206. A releasable coupler 208releasably couples clamp unit 206 to the drive unit 204. The exemplarycoupler includes an interface that provides rigid coupling betweenextensions 210 of the clamp unit 206 and proximal housing 212 of driveunit 204, and also provides moving engagement surfaces between theshafts of the clamp unit and axially moving elements of the drivelinkage. While the exemplary releasable coupler 208 includes axialpositioning surfaces (in the form of a pin of drive unit 204 andcorresponding aperture of clamp unit 206) and a releasable latch toavoid inadvertent decoupling, a wide variety of alternative releasablecouplers might also be employed. The exemplary clamp unit includes twoclamps. In some embodiments, each clamp may be individually attached toa drive unit 204. Regardless, allowing the clamps to be detached fromthe drive unit can avoid any need for making the clamps sterilizable,decreasing overall costs of the suturing system and helping to ensurethat cross-contamination between patients is inhibited. A plurality ofclamp units 206 will often be used with each drive unit 204, with eachclamp being used for a single patient and then being disposed of.

Referring still to FIGS. 11A and 11B, a variety of alternative latchmechanisms may allow quick attachment, removal, and/or replacement ofthe clamp unit 206 from the proximal portion 204 of device 202. Forexample, rather than a hinged housing portion cooperating with a pin asillustrated, a slidable housing portion may slide distally over theclamp unit interface, and optionally over some or all of the pin. Avariety of different clamp units 210 may also be provided, with theclamp units optionally having different clamp geometries to accommodatedifferent needle sizes, such as by having different offsets between thejaws when the clamps are in the closed configuration to accommodatedifferent needle thicknesses, different separation distances and/orangular offsets between the pair of clamps to accommodate differentneedle lengths, radii of curvature, or needle configurations, and/or thelike. Similarly, a plurality of different clamp units may be providedwith different body extension lengths, bend angles, or thicknesses,and/or the portion of the linkage disposed within the clamp unit may beconfigured to apply a different clamping pressure to the needles (suchas by using different wedge or jaw geometry, using different springs tourge the jaws toward the closed configuration, or the like), providing asuture system that allows the user to flexibly and selectably configurethe suture device for a particular surgery.

A still further exemplary suturing device embodiment 220 can be seen inside and cross-sectional top views in FIGS. 12A and 12B. An elongateextension 222 coupling proximal housing 224 to clamps 226 may facilitateuse of suturing device 220 in endoscopic surgery or the like. In thisembodiment, actuation of drive linkage 228 is generally effected bymovement of a single articulatable handle 230 relative to a graspingbase 232 that is affixed to proximal housing 224. By allowing thesurgeon to grasp a structure that remains rigidly affixed relative tothe suturing device body with one portion of the hand, and articulatehandle 230 with the fingers of that hand, the overall position ofsuturing device 220 (and clamps 226, along with any needle supportedtherein) can be accurately maintained. As with the other embodimentsdescribed herein, a release 233 will often be provided that, whenactuated, releases a needle from both clamps and sets the two clamps ina needle-receiving configuration.

The components and use of drive linkage 228 of suturing device 220 canbe understood with reference to FIG. 13 and FIGS. 13A-13M. As generallydescribed above, drive linkage 228 includes an alternatable driveelement 230 for alternating the driving of first one and then the otherof the two clamps. Additionally, drive mechanism 228 includes analternating latch or anchor 232 for inhibiting axial movement of theclamp that is not currently being driven. Drive linkage 228 furthermakes use of a channel casing 234 in which a movable tubular shaft 236slides along an axis 238. First and second pushers 240, 242 and a conewith a rod 244 are disposed along axis 238, while a striker 246 and astop pin with a spring 248 are disposed off of axis 238.

Reviewing the sequence of actuation of these components schematically,FIG. 13A shows the components of drive linkage 228 at a beginningconfiguration (such as after actuation of the release), with both clamps226 in a configuration that is open and ready to receive a needle. InFIG. 13B, alternatable drive element 230 drives a first shaft 236distally along its axis till the shaft engages pin 248. Needle 250 isdisposed within the clamp, with the alternatable drive element 230continuing to move axially with movement of the handle.

In FIG. 13C, continuing movement of drive element 230 has produced axialmovement of pin 248 so as to compress its spring, so that the pin stopsmoving axially. As a result, continuing movement of drive element 230does not produce additional movement of shaft 236, but instead causesthe cone with its rod 244 to move within the shaft 236 till it reachesits distal position, as shown in FIG. 13D.

Additional movement by drive element 230 results in axial movement ofpushers 240, 242, causing the striker 246 to move into alignment with awindow in the shaft 236, and thus allowing the striker to engage andreposition latch 232. As the reconfigured latch 232 inhibits proximalmovement of shaft 236, the handle may be returned (often to its extendedposition, as can be understood with reference to FIG. 13F) withoutmovement of shaft 236.

Once the handle returns to its starting or extended position, needle 250may be inserted into and through the tissue. Returning of the handlealso reconfigures alternatable drive element 230 to engage the other,previously non-driven clamp actuation components, with the other shaft236 again moving distally along its axis due to movement of the handleto engage and compress pin 248 (as seen in FIGS. 13H and 13I), inducingaxial movement of the cone and rod 244 and allowing the associatedstriker to again reconfigure the alternatable latch 232 (see FIGS. 13Jand 13K). Reconfiguring the latch allows the extended, non-driven clamp226 to retract proximally to the configuration shown in FIG. 13L underthe influence of its proximal return spring, this retraction optionallyoccurring quite quickly. The handle may now again be released, with thereconfigurable drive element 230 again being reset to alternate thedriven and latched clamps, as shown in FIG. 13M.

Structures and methods which inhibit gradual displacement of needle 250relative to suturing device 220 during repeated cycling of drive linkage228 can be understood with reference to FIGS. 13I and 13K. As each clamp226 is extended to grasp needle 250, the clamp advances distallyslightly beyond the eventual location at which the clamp will hold theneedle for suturing. This stresses and/or displaces the needle slightly,and the clamp then grasps the needle at the extended location. Theextended location will typically be less than 20 diameters of the needlepast the other clamp, typically being a few needle diameters distal ofthe other clamp (smaller needles generally employing smallerstress-inducing distances). The grasping clamp that is to retain needle250 is retracted slightly to the grasping location and the other clampis opened, so that needle 250 is positioned for the next cycle, i.e., sothat the other clamp will again stress the needle before it is grasped.This slight alternating overshoot during grasping of the needle helpsmaintain the needle near the proximal end of the grasping jaws duringcycling. The needle may also be manually pre-angled by the surgeon,either proximally or distally, to facilitate proximal or distalsuturing. For example, the distal tip of the needle may extend or angledistally of the grasping clamps, rather than the needle being disposedperpendicular relative to the axes of the shafts. Cycling of drivelinkage 228 will largely reproduce and maintain the grasping angle asthe clamps alternatingly grasp the needle, with some gradual trendtoward a perpendicular needle induced by the alternating overshootduring large numbers of actuator linkage cycles (for example, withmovement of the distal portion of the needle proximally along the jawsby a few needle diameters or less with each cycle). Hard metal insertswith small protrusions or teeth along the grasping jaw surface may alsobe beneficial to limit inadvertent movement of the needle relative tothe jaws.

Referring now to FIGS. 14A-14C, a wide variety of alternative suturingdevice clamping arrangements may also be employed. An axially concentricsuturing device 260 is particularly well suited for use with a ski-jumpneedle 262. Such needles may comprise a proximal straight section and adistal curving section, and may be commercially available from a numberof suppliers with suture affixed thereto (not shown). A proximal clamp264 and distal clamp 266 have clamping jaw members which separate androtate away from needle 262 to allow the needle to be inserted intotissue (in the configuration of FIG. 14A). The drive system may transferthe needle between the two clamps (FIG. 14B), and allow the needle to bepulled distally free of the tissue (in the configuration of FIG. 14C),with the clamps opening and closing with the cycling of a handle usingdrive elements that may be similar to, analogous to, or quite differentthan at least some of the drive components described above.

Referring now to FIG. 15, an alternative suturing device 270 may makeuse of many of the drive components described above, but may include asingle clamp 272. Rather than passing a needle back and forth betweentwo clamps, suturing device 270 may be used in a manner analogous tostandard needle drivers, and may be particularly well suited for use inthe endoscopic or other minimally invasive surgeries.

FIG. 16 schematically illustrates a suturing device 280 similar to thatof FIGS. 12A and 12B, with extension 282 between clamps 284 and proximalbody housing 286 here having a bend 288. While such suturing devices mayoptionally be sold in a pre-bent configuration, bend 288 mayalternatively be imposed by a surgeon, with the surgeon manually (oroptionally, with the assistance of one or more tools) bending theextension (or another structure supporting the clamps) to a desiredconfiguration for use in a surgical procedure on a particular patient.Extension 282 may be formed of a material (typically comprising a metalor polymer) which can withstand bend 288 while maintaining structuralintegrity of the suturing device, and the drive components which movewithin bend 288 (such as the axially movable shaft, rod with a cone, orthe like) may be formed of a material (or having a configuration) whichcan accommodate lateral deflection within the bent tubular extensionduring the actuation, such as by forming drive components of a suitablepolymer, making use of at least a portion of the drive components whichare formed as a helical coil, including thin, flexible sheet metalcomponents, or the like. In general, reconfiguring the drive componentsor support structures to employ bent sheet metal parts may also helpreduce manufacturing costs, and the like. Hence, the shaft may (forexample) comprise a sheet metal structure with end tabs having openingsto receive components therein, and/or the like. The positive control orpositioning of clamps 284 which can be available using a grasping basethat's originally affixed to the body housing 286 when suturing device280 is held by a hand H of a surgeon can also be understood withreference to FIG. 16.

Referring now to FIG. 17A-D, another alternative suturing device 402 hasa housing with an extension extending along an axis 406 from a proximalhandle 408 to a distal clamp 410. A linkage mechanism 412 transmitsmotion from handle 408 to clamp 410, via axial movement of a shaft 414,the shaft here being formed as an axial series of ball elements 416.Each ball element may, for example comprise a spherical structure, withor without an indentation to receive an adjacent ball element and allowsliding motion therebetween. Regardless, the shaft is stiff incompression to allow the linkage to push a wedge between slidingsurfaces of the jaw structure, as can be understood from the descriptionabove and the side cross-sectional illustration of FIG. 17C. A top viewof the clamp 410 is seen in FIG. 17B.

Extension 404 is plastically bendable, allowing the user to impose acustom bend on axis 406. The metal or other plastically bendablematerial of the extension will, when bending with shaft 414 therein,avoid kinking or collapsing so as to interfere with articulation oflinkage 412. The user will grasp and articulate the handle with thefingers and the thumb of the hand, and a simple ratchet 422 (see FIGS.17A and 17D) can releasably maintain the clamp in the graspingconfiguration.

Suturing devices having bendable or pre-bent extensions may find use ina wide range of open and minimally invasive surgical procedures,including endoscopic procedures, therapies of the ear, nose, and throat(ENT procedures), particularly for oral surgery and the like. Bendableor pre-bent devices and structures may be combined with suturing devicesand systems described above, including those having a plurality ofdiffering alternative clamp units to allow configuration of the suturingdevice for a particular therapy or patient, including clamp units havingsingle clamps, multiple clamps of a similar type, multiple clamps ofdifferent types, and the like. Other capabilities may also be included,such as including a light cable or waveguide supported by and extendingalong the extension to help illuminate the workspace, includingaspiration and/or irrigation lumens that extend axially along theextension, or the like. Hence a wide variety of alternative devices,systems, and methods may be employed.

Referring now to FIGS. 18A-18C, an alternative embodiment of a suturingassembly 502 may include a drive unit 504 supporting a clamp unit 506via a quick-disconnect interface 508. As described and shown above inFIGS. 11A and 11B, a handle 510 of the drive unit may articulaterelative to a drive unit body 512 so as to articulate the clamps via alinkage, with a portion of the linkage being supported by the drive bodyand a portion being integrated into the clamp unit. Coupling of a shaftportion of the drive unit to a corresponding shaft portion of the clampunit (with the shaft of the linkage articulating the clamps as describedabove) may be facilitated, for example, by having springs which positionthe shaft portions of the clamp unit in preparation for engagement, byhaving axially engagement surfaces which laterally receive and axiallyposition the shaft portions relative to each other, and the like (as canbe seen in FIGS. 18A-18C, 24A, and 24B). An axial positioning feature(such as a laterally extending post or the like) and associatedreceptacle of interface 508 can axially position a body of the clampunit relative to the drive unit body 512, with coupling of the interfacebeing maintained in the embodiment of FIG. 18A-18C by sliding a coverdistally 514 so as to laterally restrain the clamp unit.

Referring now to FIG. 19, a suturing system 520 employing many of thecomponents of FIGS. 18A-18C can facilitate suturing with any one or moreof a relatively large suture needle 522 a, a medium size suture needle522 b, and/or a small suture needle 522 c. More or fewer needles may beused, and the needles may vary in both size and type. The needles mayalso each have a standard size or type identifier, exemplary needlescomprising a CTX, a CT-1, a PS-2, and/or the like, with the needlegeometry (such as the needle length, any angular are defined by theneedle, the radius of curvature of the are, the thickness of the needle,and the like) varying with the needle identifier. Each needle used withthe system will have at least one clamp unit 522 a, 522 b, 522 cassociated therewith, with the clamp unit having a geometry suitable foruse with the associated needle geometry.

When it is desired to make use of a needle of a particular size (such asa CT-1), the associated clamp unit is then selected and mounted to thedrive unit 504. As the clamps of the clamp unit are correctly positionedfor use with the needle, the system can be used to manually suture afirst target tissue by cycling the handle to alternate between clamps,moving the drive unit body to effect corresponding movements of theneedle into and then out of the tissue, and the like (as describedabove). When it is then desired to target a different target tissue thatwould benefit from a different needle size, a new clamp unit is selectedbased on the new needle size. The prior clamp unit is removed andreplaced from the interface of the unit, with the new clamp unit, havingdifferent clamp geometries which correspond to those of the newlyselected needle. The suturing may then proceed by cycling the handle toalternate clamps, etc. Once the patient has been closed, the clamp unitsmay be disposed of to avoid cross-contamination, and the drive unit maybe sterilized. Alternative methods may sterilize and/or otherwiseprocess (such as by reconditioning, remanufacturing or the like) some orall of the clamp units for use with one or more other patient, forexample, so long as the clamp units are within acceptable condition forsafe use.

Referring now to FIGS. 19 and 20A-20C, additional aspects of thecorrespondence between clamp geometry and needle geometry areillustrated. For example, there may be a relationship between theappropriate spacing and angular offset of the clamps for a particularneedle, so that one or both may varied between different clamp units fordifferent needle sizes. Needle 522 b is held by clamps 524 b, 526 b ofclamp unit 506 b. Needle 522 b has an axis 528 that curves along an areangle and axial arc length between the clamps. The clamps are angularlyoffset by angle 530 b. As needle 522 a is larger, the angular offset 530a between clamps 524 a, 526 a of clamp unit 506 a may differ from thatof the clamp unit 506 b. Maintaining separation between the clamps ofdifferent clamp units allows the use of a drive system which actuate theclamps along parallel actuation axes. However, to fully take advantageof the ability of larger needle 522 a to place larger stitches in asuture, the spacing between clamps may be increased, as seen by thedistance between clamps 524 a′, 526 a′ in FIG. 20C. A wide variety ofadditional aspects of the clamp units may be tailored to the associatedneedle size, type, and/or geometry. For example, large needles maybenefit from increased gripping force to withstand the moments andforces imposed when suturing, while smaller needles may benefit fromlighter gripping forces so as to inhibit excessive stress and strain onthe needles (particularly when the smaller needles are highly curvedwith axes defining small radii). Typical gripping forces may be betweenabout 2 and about 50 pounds, optionally being between about 5 and about40 pounds, and in the same cases may be about 30 pounds for medium sizedneedles, with much smaller needles optionally being less and much largerneedles optionally being more. Separation distances between the grippingsurfaces of the clamps may decrease to accommodate thinner needles, thesize and/or configuration of the gripping surfaces may be varied, andthe like.

FIGS. 21A-21C illustrate an embodiment of a suture system 540 having aclamp unit 542 with separately movable extensions 544 a, 544 b, for eachclamp. In this embodiment, each extension 544 a, 544 b is supported by aclamp unit body 546 via a cam-and-follower arrangement 548, so that whenthe clamps are distally extended for grasping needle 522 a, they angleoutwardly away from each other (moving from the drive unit toward theneedle). This will facilitate grasping of different length needles withdifferent clamp separation distances while still using a common driveunit 550. Note that the angle need not be defined at all times by theclamps and their associated support and actuation structures,particularly when they are retracted proximally from the needle. As canbe understood with reference to FIGS. 22A and 22B, clamp separationdistances 552 a, 552 b may be different for different clamp units 554 a,554 b used with different sized needles, even when the angles 556between extensions are the same, particularly when the extensions aresignificantly different in length.

Referring now to FIG. 20C and the related views ZZ of FIGS. 23A-23C, thealternating overshoot or slight deformation of the needle prior tograsping the needle with each clamp described above may help to bothposition the needle relative to the clamps and orient the needlerelative to the clamps, even when different needles are used with thesame drive unit. As generally described above, each clamp unit has afirst clamp and a second clamp, and each clamp has a fist jaw with agripping surface, a second jaw with a gripping surface, an openably jawaperture 560 between the gripping surfaces, and at least one jaw backsurface 562 extending between the jaw surfaces opposite the jawaperture. As can be understood from the above (in large part withreference to FIGS. 11A, 11B, and 13A-13M), the linkage portion of thedrive unit operationally couple the clamps of the mounted clamp unit sothat a first cycling of the linkage portion of the drive unit drives thefirst clamp 526 a′ distally beyond a needle gripping location (seen inFIG. 23A) so as to promote engagement between the jaw back surface ofthe first clamp 526 a′ and the associated needle 522 a (seen in FIG.23B). The first clamp is then closed so as to engage the grippingsurfaces of the first clamp against the associated needle. Clamp 526 a′then retracts back to the needle gripping location (see FIG. 23C), andthe second clamp 524 a′ can be opened and proximally withdrawn.

The overshoot draws or walks the needle back into the back surface ofthe jaw (so as to position the grasped portion of the jaw in space). Theclamping of the needle in the jaws also 10 tends to axially align theorientation of the jaw articulation axis with the adjacent needle axis,and repeating the overshoot and grasp process with the other clamp 524a′ (which is angularly and positional offset from clamp 526 a′) mayaccommodate and correct for both positional and orientationalmisalignment between the needle and clamps. This may avoid any need torely entirely on groves or notches in the gripping surfaces that couldcause the needle to be dropped when misalignment occurs. While theprecise position of the clamps axially along the needle may be lesstightly controlled by this approach than the other degrees of freedom ofthe needle, the system is quite tolerant in that orientation, forexample, being very workable despite having the system user manuallypositioning of the clamps anywhere along a relatively wide axial rangeof the needle.

Referring now to FIGS. 24A-24C, articulation of clamp unit 542 of FIGS.21A-C is shown in an initial position with the clamp 570 grasping a CTXneedle in FIG. 21A. The extension structure supporting extended clamp570 angles distally outwardly, while the structure supporting theretracted clamp 572 is parallel to a midline of the system. As thesystem cycles, cam-and-follower arrangement 548 causes the extensionsupporting clamp 572 to also angle outwardly as you move distally alongthe extension, with the clamps extending along axes having an angle 576therebetween when both are grasping the needle 574 as seen in FIG. 24B.Clamp 572 then retracts and moves toward the mid-line to complete thealternating of the clamps.

Note that FIGS. 24A-24C also show indicia 580 of a needle sizeassociated with the clamp unit on the clamp unit body. Alternativeindicia of the associated needle is also seen in the mounted clamp unitof FIG. 25C. The exemplary indicia shown may reference needles (and Lorthe associated suture) commercially available from Ethicon, a Johnson &Johnson company, though alternative indicia may reference needles fromother suppliers, or may be generic regarding the needle source. Suchindicia may comprise a written indication of or identifier for theassociated needle, a color code associated with the needle size, aproprietary or generic needle code, needle name, needle symbol, needlenumber, or the like. A range of needle sizes, shapes, or types may beassociated with the indicia of a single clamp unit, or the indicia maybe specific to a particular needle geometry from a particular supplier.The indicia may reference a single needle or list a plurality of needlesof different needles from different manufacturers, or may reference aseparate chart, listing, or description of multiple needles compatiblewith the clamp unit. The indicia may graphically indicate acceptableneedle sizes, for example, by including a scale, illustrations ofminimum and maximum compatible needle sizes for comparison to an actualneedle, or the like. The indicia may reference the suture materialpre-packaged with the compatible needle model by the needle supplier insome embodiments. The indicia may be embossed on the clamp unit,attached to the clamp unit as a sticker, painted on the clamp unit, orthe like, and the clamp unit body may include a recess to receive theindicia. FIGS. 25A and 25B show two different and alternativelyselectable clamp units having different needle identifies thereon so asto facilitate selection of an appropriate clamp unit for a particularsuture needle. In these embodiments, different cam-and-followerarrangements vary the clamp separations.

FIG. 26 shows yet another alternative clamp unit 580 that may be used inplace of those of FIGS. 25A and 25B in the clamp system of FIG. 21A,with clamp unit 580 having an elongate extension body 584 extendingbetween a drive unit interface 582 and the clamps. Such an extensionbody may be configured for endoscopic surgeries, such as by having around cross-sectional shape suitable for insertion through a minimallyinvasive access port structure or the like. Extensions of alternativelengths, cross-sectional sizes, and the like may be provided so as tofacilitate surgeries of different types using the same drive unit. Inother embodiments, at least a portion of the extension may beincorporated into a drive unit intended for minimally invasivesurgeries.

While exemplary embodiments of the invention have been described indetail, by way of example and for clarity of understanding, a variety ofmodifications, changes, and adaptations will be obvious to those ofskill in the art. For example, along with the exemplary drive linkagesdescribed herein, still further drive linkages may be provided,including those making use of cables and pulleys, worm gears, and thelike. Hence, the scope of the present invention is limited solely by theappended claims.

What is claimed is:
 1. A suturing system for use with a first suturing needle or a second suturing needle, the system comprising: a body having a proximal end and a distal end; at least one clamp mountable near the distal end of the body; a linkage effecting a movement of the at least one clamp between a grasping configuration and a released configuration when the linkage cycles, the linkage having a first configuration and a second configuration, the linkage in the first configuration applying a first clamping suitable for suturing with the first suturing needle when the linkage effects movement from the released configuration to the grasping configuration, the linkage in the second configuration applying a second clamping suitable for suturing with the second needle when the linkage effects movement from the released configuration to the grasping configuration.
 2. The suturing system of claim 1, the first needle defining a first are, the second needle defining a second arc different than the first arc, the suturing system further comprising: a first clamp unit and a second clamp unit, each clamp unit removably mountable to the body and including an associated plurality of clamps, the clamps sequentially grasping an associated needle when the clamp unit is mounted to the body and the linkage is cycled; wherein the clamps of first clamp unit define a first clamping offset angle corresponding to the first arc, and wherein the clamps of second clamp unit define a second clamping offset angle corresponding to the second are, such that replacement of the first clamp unit with the second clamp unit reconfigures the linkage from the first configuration to the second configuration.
 3. A suturing system for use with a first suturing needle having a first needle geometry and a second suturing needle having a second needle geometry different than the first needle geometry, the system comprising: a drive unit having a body with a proximal end and a distal end; a first clamp unit mountable near the distal end of the body and including a plurality of clamps; a second clamp unit mountable near the distal end of the body and including a plurality of clamps; a linkage operationally coupling the drive unit to an associated clamp unit mounted thereon, the linkage effecting sequentially alternating grasping and releasing by the clamps of the first clamp unit when the first clamp unit is mounted to the drive unit and the linkage is cycled, the grasping of the first clamp unit corresponding to the geometry of the first needle; the linkage effecting sequentially alternating grasping and releasing by the clamps of the second drive unit when the second clamp unit is mounted to the drive unit and the linkage is cycled, the grasping of the second clamp unit corresponding to the geometry of the second needle.
 4. The suturing system of claim 3, wherein the clamps of the first drive unit are laterally separated so as to grasp the first needle near opposed ends of the needle, wherein cycling the linkage effects needle movement relative to the body which is insufficient to advance the first needle through tissue so that suturing can be effected by moving the body relative to the tissue.
 5. The suturing system of claim 3, wherein each clamp articulates with cycling of the linkage so as to grasp the needle laterally relative to a local axis of the needle, wherein the clamps of the first clamp unit are angularly offset by a first angle so as to accommodate a first arc angle of the first needle geometry between the clamps, and wherein the clamps of the second clamp unit are angularly offset by a second angle so as to accommodate a second arc angle of the second needle geometry between the clamps, the offset angle of the first clamp being different than the second offset angle of the second clamp.
 6. The suturing system of claim 3, wherein each clamp articulates with cycling of the linkage so as to grasp the needle laterally relative to a local axis of the needle, wherein the clamps of the first clamp unit separated by a first separation distance so as to accommodate a first arc length of the first needle geometry between the clamps, and wherein the clamps of the second clamp unit are separated by a second separation distance so as to accommodate a second arc length of the second needle geometry between the clamps, the first separation of the first clamp being different than the second separation of the second clamp.
 7. The suturing system of claim 6, wherein first and second extension portions of the first clamp unit each support an associated clamp, the first and second extension portions angling per an extension angle along a first length between the body of the drive unit and the first needle when in use.
 8. The suturing system of claim 7, wherein first and second extension portions of the second clamp unit each support an associated clamp, the first and second extension portions angling per the extension angle along a second length between the body of the drive unit and the first needle when in use, the second length being different that the first length.
 9. The suturing system of claim 3, wherein the clamp unit comprises polymer, and wherein needle engaging surfaces of the clamp unit comprise metal, the clamp unit comprising a disposable clamp unit.
 10. The suturing system of claim 3, wherein the drive unit comprises metal and is configured to withstand repeated sterilization.
 11. The suturing system of claim 3, wherein the each clamp unit has indicia of an associated needle size visible thereon so as to facilitate selection of an appropriate clamp unit for use.
 12. A suturing system for use with a plurality of differing suturing needles, the system comprising: a drive unit having a body with a proximal end and a distal end; a plurality of alternative clamp units releasably mountable to the distal end of the drive body, each clamp unit having a plurality of clamps for engaging an associated plurality of locations of an associated needle, the clamps of the clamp units defining different geometries so as to accommodate the differing needles and their use for suturing differing tissues.
 13. The suturing system of claim 12, each suturing needle being an off-the-shelf suturing needle having a standard size identifier associated therewith, wherein each clamp unit has a visible indicia of the size identifier of an associated needle. 